JVT Advisors

QC Data Reviewer

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6+ months
Job Summary:  This person will interact across various levels of personnel from individual contributors to QC and QA management to critically review both paper and electronic analytical data generated via GMP QC Bioassay methods.
  • Review and approve GMP Quality Control Bioassay test records per approved procedures:
    • Ensure compliance to Good Documentation Practices
    • Verify calculations
    • Verify that appropriate test method/specification applied for sample testing
    • Data entry/approval in LIMS
  • Methodologies to review include, but are not limited to, Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, qPCR, SDS-PAGE gels, protein concentration determination, cell-based ELISA and in vitro potency assays.
  • BS in a relevant scientific discipline with Quality Control experience in a cGMP-based laboratory setting with a focus in Molecular/Cell Biology or Biochemistry
  • Understanding of Sanger Sequencing, qPCR, ELISAs and potency assays
  • Working knowledge of relevant and current FDA, EU, EMA, ICH guidelines and regulations preferred
  • Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment  
  • Excellent communication skills (verbal and written)Ability to perform responsibilities with high attention to detail

Jared Potter

Principal Recruiter

He's a natural people person.

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